Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis

NCT06424912 | Recruiting

• 1 other identifier: CIP-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The study objective is to evaluate the safety and feasibility of the Vivifi's Treatment. The Vivifi's Treatment presents an innovative approach for addressing benign prostatic hyperplasia (BPH) as well as clinical/subclinical varicoceles in men. The scientific rationale for conducting this study is to assess the safety and feasibility of the Vivifi's Treatment (a surgical procedure) as a therapeutic intervention for patients with BPH.

Conditions

Benign Prostatic Hyperplasia; Varicocele Grade II; Varicocele Grade III

Keywords

BPH; Varicocele

Outcome Measures

Primary Outcomes (2)

• PRIMARY SAFETY ENDPOINT

  Assess the safety of the Vivifi's Treatment through the rate \& type of the procedure related complications, such as bleeding, infection or other tissue damage.

  will be assessed up to 12-month post-procedure follow-up.

• PRIMARY EFFICACY ENDPOINT

  Assess the changes in International Prostate Symptoms Score (IPSS) from baseline to post-procedure. The score range of the questionnaire is 0 to 35. A higher score indicates worse symptomatic.

  to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.

Secondary Outcomes (4)

• SECODARY EFFICACY ENDPOINT 1

  to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.

• SECODARY EFFICACY ENDPOINT 2

  to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.

• SECODARY EFFICACY ENDPOINT 3

  to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.

• SECODARY EFFICACY ENDPOINT 4

  to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.

Study Arms (1)

Treatment Group

EXPERIMENTAL

Subjects undergo Vivifi's surgical procedure for treatment of BPH.

Procedure: Vivifi's Surgical Procedure

Interventions

Vivifi's Surgical Procedure PROCEDURE

Subjects undergo Vivifi's surgical procedure for treatment of BPH. The study procedure will be performed in the operating room, under general anesthesia. Subject will undergo a bilateral anastomosis of the internal spermatic vein to the inferior epigastric vein and ligation of the deferential vein via bilateral inguinal/subinguinal incision. The investigators can use of a coupler with appropriate ring size (to be measured intra-operatively based on vessel size) to perform the vascular anastomosis and standard sutures for ligation. The coupler is an FDA approved commercial device. Alternatively, the anastomosis can also be performed using sutures. Incision closure will proceed per institution standard of care.

Treatment Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male 40-75 years of age
• Diagnosed with Benign prostatic hyperplasia (BPH)
• Prostate volume: ≥ 30 ≤ 120 cc measured by transrectal ultrasound
• Signed the study informed consent form (ICF)
• Presence of Lower Urinary Tract Symptoms (LUTS) measured by International Prostate Symptoms Score (IPSS) greater than 12
• Presence of clinical varicocele (preferably grade II or III - Dubin \& Amelar.

You may not qualify if:

• Patients with prior history of spermatic vein or pampiniform plexus related surgeries or impairment, or vasectomy
• Previous invasive prostate intervention (TURP, laser, ablation, prostate artery embolization, etc.)
• Prostate with large intravesical median lobe
• Patients with sub-clinical varicocele
• Post-void residual volume (PVR) \> 110ml
• IPSS (International Prostate Symptoms Score) \>24
• Patients with clinical history of chronic prostatitis.
• Patients with clinical history of urinary retention with previous need for catheterization (prior 30 days).
• Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury
• Patients that can not be under general anesthesia
• Patients on blood thinners, or with coagulation related issues, TTP
• Prior pelvic floor surgery or condition such as inguinal hernia, mesh, etc
• History of cancer in genitourinary system, which is not considered being cured. A potential participant is considered cured if there has been no evidence of cancer within five years of the study.
• Inability to provide legally effective Informed Consent Form (ICF) and/or comply with all of the required follow-up requirements
• Subject currently participating in other investigational studies unless approved by the Sponsor in writing

Sponsors & Collaborators

• Vivifi Medical: lead
• RQM+: collaborator

Study Sites (1)

Hospital Paitilla

Panama City, Provincia de Panamá, Panama

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia; Varicocele

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nathan Starke, MD

  Vivifi Medical (Chief Medical Officer)

  STUDY CHAIR

Central Study Contacts

Yunlong Zhang, Master of Science

CONTACT

669-203-9308; pzhang@rqmplus.com

Tushar Sharma, CEO of Vivifi (Study sponsor)

CONTACT

tushar@vivifimedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, non-randomized first-in-man study

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 22, 2024
• Study Start: November 13, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

PA (1)